Senior Clinical Database and Reports Developer

Olympus Corporation of the Americas•Upper Saucon, PA

7d•$128,775 - $180,285•Remote

About The Position

As part of the Medical and Scientific Affairs group within Global Clinical Affairs, the Senior Clinical Database Developer is responsible for leading the design, development, and ongoing maintenance of clinical study databases supporting global medical device clinical trials. This role serves as a technical subject matter expert for Electronic Data Capture (EDC) platforms, including Medidata, and partners closely with Clinical Data Management, Clinical Operations, Biostatistics, and IT to deliver high-quality, compliant, and efficient data capture solutions. The Senior Clinical Database Developer leads database programming activities across the study lifecycle, including EDC build, edit check and validation programming, and testing activities. This role also develops, programs, and tests custom study reports and dashboards to support data oversight, operational monitoring, and senior leadership decision-making. In addition, this role serves as a systems administrator for clinical data platforms and databases, managing user access, roles and permissions, system configuration, and ongoing operational support to ensure data integrity, security, and compliance.

Requirements

Bachelor’s degree in computer science, Life Sciences, Engineering, or a related field (or equivalent experience).
Bachelor’s degree with a minimum of 8 years of experience in clinical database development/programming within medical device, pharmaceutical, or biotechnology environments, OR Master’s degree with a minimum of 6 years of experience in clinical database development/programming within medical device, pharmaceutical, or biotechnology environments.
Strong hands-on experience with Medidata Rave (study build, edit checks, UAT, reporting).
Demonstrated experience building EDC databases, programming edit checks and validations and supporting live clinical studies.
Experience developing custom reports and dashboards for clinical trial oversight.
Solid understanding of clinical trial processes and regulatory requirements (FDA, ICH-GCP).
Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills. (Rave Custom Function Programming skills are mandatory).
Experience with BI/reporting tools (SAP Business Objects, Oracle Business Intelligence, Medidata Reporter, Looker, and/or SAS). Applied knowledge of Medidata suite of applications (e.g., Platform CTMS, RTSM, TSDV, Coder) and their integrations preferred.
In-depth knowledge of ICH-GCP, FDA/EMA regulations, and GCDMP.
Strong expertise in implementing and maintaining systems for global medical device trials (Class II/III or combination products)
Excellent stakeholder management skills with cross-cultural sensitivity and global collaboration experience
Strong experience in vendor management and system validation
Ability to collaborate effectively with the study team, cross-functional team members and external partners.
Excellent verbal and written communication skills and interpersonal skills are required.
Excellent analytical, organizational, and communication skills.
Ability to manage multiple priorities in a fast-paced environment.
Proficiency with clinical data systems and MS Office Suite.
Position may require some travel.
Candidates must be authorized to work in the U.S.
Occasional meetings out of normal working hours will be required as this role supports a global team (EMEA, Japan, China, APAC).

Responsibilities

Design, develop, document, test and/or support clinical study databases and configuration of cross-system interfaces per business process.
Drive the design, development, testing, and/or maintenance of custom clinical reports and dashboards, clinical data transfers, or other components related to clinical studies.
Lead programming, testing, and documenting of study edit checks and validations.
Understand industry standards and apply them.
Partner as clinical technical specialists in the planning, designing, and implementing of clinical applications.
Provide technical consultation on, and task directions for vendors
Mentor junior team members.
Stay current on technologies, methods, standards, and best practices as well as trends and direction of the clinical data management industry.
Demonstrate excellent interpersonal skills, especially the ability to communicate, advocate, negotiate, listen and partner with a variety of individuals and groups.